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Wednesday, February 9 • 1:45pm - 2:15pm
Panel: Mitigating Risks in a Restricted Distribution Environment

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  • Review entities involved in the restricted distribution REMS, what is their level of involvement in risk minimization?
  • Describe the role of REMS Development, Operations, and Quality Management in ensuring compliance with the requirements
  • Discuss the correlation between compliance level and REMS effectiveness
  • Break down the risk-based approach in risk minimization for all entities in a restricted distribution model
  • Share perspectives on the utilization of Quality Risk Management in the REMS space
Moderators
avatar for Marc DeLuca

Marc DeLuca

US Risk Management Lead, Sanofi
Marc DeLuca is a healthcare systems engineer and has spent 20+ years in the pharmaceutical risk management space.  Blending his knowledge of systems engineering with his experience in the pharmaceutical industry, Marc has been involved in a range of activities involving project management... Read More →

Speakers
avatar for Nancy Dubois

Nancy Dubois

Associate Director, Local Safety Officer, US Region, AstraZeneca
As a trained clinician, Dr. Dubois has over 25 years of experience in successfully driving pharmaceuticals and medical devices through the product life cycle and to market approval. Dr. Dubois has held key roles in both academic and for profit pharmaceutical clinical research programs... Read More →
avatar for Kal Elhoregy

Kal Elhoregy

Director, Risk Evaluation and Mitigation Strategy (REMS) Programs - Regulatory Affairs Clinical, Amneal Pharmaceuticals
Kal Elhoregy is an accomplished healthcare industry executive with 24+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems (QMS) and Pharmacovigilance (PV) Compliance within the pharmaceutical industry. In his current role as a Director... Read More →

Wednesday February 9, 2022 1:45pm - 2:15pm EST
  REMS